Daubert Déjà Vu

Plaintiff’s expert is excluded for relying on a “novel” methodology to support opinion that antidepressant drug causes birth defects.

On June 27, 2014, in In Re: Zoloft, U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania issued an opinion excluding an expert in a case that bears a striking resemblance to the facts of Daubert v. Merrell Dow. We think Judge Rufe’s decision in Zoloft will serve as useful precedent to the defense bar and their clients in future pharmaceutical product liability litigation.

In Zoloft, Judge Rufe excluded plaintiff’s epidemiological expert. She found that the expert departed from “well-established epidemiological methods” to support her expert opinion that the antidepressant drug Zoloft caused birth defects. Judge Rufe’s 24-page decision explains the specific criteria followed by the scientific community when analyzing the issue of whether a drug causes birth defects. In the scientific field of teratology (which deals with the cause and prevention of birth defects) epidemiologists who study the possible adverse effects of a drug taken during pregnancy must rely on observational evidence. Since their research involves pregnant women and their unborn fetuses, epidemiologists do not have the benefit of relying on the kind of data obtained from clinical trials that is typically available in other types of epidemiological studies. Due to the outside factors that can impact the results of these studies, the teratology community requires “consistent statistically significant human epidemiological findings” before concluding that there is a “true” association between a medication and an adverse outcome.

In Zoloft, the plaintiff offered the expert opinion of Dr. Anick Berard, a perinatal pharmacoepidemiologist, who opined that Zoloft when used during pregnancy is capable of causing a range of birth defects. After holding a Daubert hearing, Judge Rufe held that Dr. Berard’s opinions failed to meet the minimum standard for a “true” association that is strived for in teratolgy research. Dr. Berard was offering an opinion that was not grounded in the methods and principles of the teratology scientific community. The Judge noted that Dr. Berard was selective in the data she considered and that she failed to address scientific studies that indicated there is no conclusive evidence of an association between Zoloft and birth defects. Dr. Berard had also published contradictory opinions in 2007 and 2012.

In short, the research on which the plaintiff’s expert relied was not supported by other researchers in the relevant scientific field. Judge Rufe also noted that some researchers “go further and advocate the use of Zoloft as a first-line drug for treating depression in pregnancy,” which also contradicted the plaintiff’s expert’s opinion.

For practitioners and litigants engaged in the defense of product liability litigation, this case is a “must read.” It is a detailed opinion that explains the various criteria considered by epidemiologists when examining the issue of whether a medication has an adverse effect on pregnancy.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

- hide

Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.